MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT W/ JRNY LK SZ 5-6 11; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71933737
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to patient required a poly exchanged after being in a car accident.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT W/ JRNY LK SZ 5-6 11
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7292098
• Report Number: 1020279-2018-00229
• Device Sequence Number: 1355505
• Product Code: JWH
• UDI-Device Identifier: 00885556064399
• UDI-Public: 00885556064399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Catalogue Number: 71933737
• Device Lot Number: 10CM16680
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 05/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention